China's NMPA Approves Ecnoglutide, the First cAMP-Biased GLP-1 Receptor Agonist for Chronic Weight Management
Sciwind Biosciences announced on March 6, 2026, that China's National Medical Products Administration (NMPA) has approved ecnoglutide injection for chronic weight management in Chinese adults with overweight or obesity. The decision makes ecnoglutide the first cAMP-biased GLP-1 receptor agonist to receive regulatory approval anywhere in the world for this indication. It is also the second GLP-1-based therapy cleared by the NMPA for weight management, following semaglutide 2.4 mg (Wegovy) in June 2024, and represents the second approved indication for ecnoglutide in China, after its earlier clearance for type 2 diabetes.
The NMPA approval covers use as an adjunct to lifestyle intervention in adults with obesity (BMI ≥28 kg/m²) or overweight (BMI ≥24 kg/m²) with at least one weight-related comorbidity. Ecnoglutide is administered as a subcutaneous injection. The company said the molecule selectively activates the cAMP signaling pathway downstream of the GLP-1 receptor while minimizing β-arrestin recruitment, a mechanism it describes as distinct from conventional balanced GLP-1 receptor agonists such as semaglutide and liraglutide.
The approval was supported by the Phase 3 SLIMMER trial, a randomized, double-blind, placebo-controlled study conducted in Chinese adults with overweight or obesity. Results, published in The Lancet Diabetes & Endocrinology in June 2025 and presented at the American Diabetes Association and European Association for the Study of Diabetes annual meetings, showed that the 2.4 mg dose of ecnoglutide produced a mean body weight reduction of 15.4% from baseline at 48 weeks, corresponding to a placebo-adjusted loss of 15.1%. Among participants receiving the highest dose, 92.8% achieved at least 5% weight loss, while 79.6% and 63.5% reached thresholds of 10% and 15%, respectively. The company noted that weight loss continued at 48 weeks without evidence of a plateau. Secondary endpoints showed reductions in waist circumference, blood pressure, lipid levels, HbA1c, fasting glucose, insulin resistance (HOMA-IR), and uric acid. In a subgroup with baseline liver fat content of 8% or higher, the 2.4 mg group showed a mean reduction in liver fat of 53.1% at week 40. Gastrointestinal adverse events were the most commonly reported, consistent with the GLP-1 receptor agonist class, and were described as predominantly mild to moderate.
The approval arrives at a time of rapid expansion in the pharmacotherapy of obesity, both in China and globally. In China, the prevalence of overweight and obesity continues to rise, and the condition is now recognized as the sixth leading risk factor for death and disability in the country, the company said. Until recently, pharmacologic options for weight management in China were limited, with orlistat among the few available agents. The NMPA's approval of semaglutide 2.4 mg in 2024 marked a shift, and ecnoglutide now adds to a growing field of GLP-1-based therapies available to Chinese patients. Ecnoglutide joins a competitive landscape that includes not only semaglutide but also tirzepatide (Zepbound), a dual GIP/GLP-1 receptor agonist from Eli Lilly that is under regulatory review in China, and mazdutide, a dual GLP-1/glucagon agonist from Innovent Biologics in Phase 3 development for the same indication. Globally, the obesity pipeline has expanded further, with triple agonists such as retatrutide, amylin-GLP-1 combinations like CagriSema, and oral non-peptide GLP-1 receptor agonists including orforglipron all in late-stage trials. Whether ecnoglutide's biased-agonism mechanism translates into differentiated tolerability or durability relative to these agents remains to be determined in head-to-head studies, which have not yet been reported. Sciwind Biosciences has indicated that global Phase 3 trials for ecnoglutide outside China are active, though timelines for regulatory submissions in the United States or Europe have not been disclosed.
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